FDA Inspection
Granules Pharmaceuticals Inc.Granules Pharmaceuticals Inc. – FDA Inspection, Dec 15, 2023
Record Details
This FDA Inspection record concerns Granules Pharmaceuticals Inc., with an inspection on December 15, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 45371d19-7a67-4bab-ae38-48217349ea87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225087
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Granules Pharmaceuticals Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2026 | VAI | Baltimore District Office | Drug Quality Assurance |
| June 27, 2025 | VAI | Baltimore District Office | Generic Drug Evaluation |
| August 3, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2019 | Not classified | Baltimore District Office |
Other documents for Granules Pharmaceuticals Inc.
- FDA Inspection 1311002 - 2026-04-03
- FDA Inspection 1274604 - 2025-06-27
- FDA Inspection 1215034 - 2023-08-03
- FDA Inspection 1175097 - 2022-07-22
- FDA Inspection 1107374 - 2019-08-21
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